Category: Professional Posters
Purpose: HTX-011, an extended-release dual-acting local anesthetic combining bupivacaine with low-dose meloxicam in a Biochronomer polymer, has demonstrated effectiveness through 72 hours in multiple types of surgical models. In a previously conducted Phase 3 bunionectomy study (EPOCH 1), treatment with HTX-011 without background multimodal analgesia (MMA) provided superior pain relief, reduced the incidence of severe pain, significantly reduced total opioid consumption, and resulted in significantly more opioid-free patients through 72 hours than either placebo or bupivacaine hydrochloride. The current follow-on study was designed to assess the efficacy of HTX-011 when used as the foundation of a scheduled non-opioid MMA protocol.
Methods: We prospectively evaluated 31 patients undergoing bunionectomy using HTX-011 along with scheduled ibuprofen and acetaminophen. HTX-011 (60 mg/1.8 mg bupivacaine/meloxicam; 2.1 mL) was applied without a needle into the surgical site at the end of surgery before closure. Patients were kept in house for 72 hours and given a postoperative MMA regimen of oral ibuprofen 600 mg and oral acetaminophen 1 g, each given every 6 hours (alternating every 3 hours) throughout the 72-hour inpatient postoperative period (total 2400 mg ibuprofen and 4 g acetaminophen per day). Rescue opioids were available upon request. Upon discharge, patients were instructed to use 600 mg ibuprofen every 6 hours as needed and to add acetaminophen (1 g) every 6 hours if pain persisted. Only patients who received ≥10 mg oxycodone within 12 hours before discharge were to be provided an opioid discharge prescription. Efficacy assessments included pain intensity (assessed using an 11-point [0 to 10] Numeric Rating Scale [NRS]) and opioid use (assessed via concomitant opioid use while inpatient and opioid daily diary after 72 hours through Day 28). Safety assessments included adverse events and clinical laboratory tests.
Results: Baseline characteristics (mean age, 49 years; 94% female; 87% white) were similar to those of patients who received HTX-011 in the initial Phase 3 study (mean age, 48 years; 88% female; 78% white). Mean NRS pain intensity remained < 3 (out of 10, mild pain, < 4; moderate pain, 4-6; severe pain, ≥7) at all time points through 72 hours. A total of 24 patients (77.4%) required no opioids (ie, opioid-free) through 72 hours and all remained opioid-free through the 28-day recovery period. To compare, in the Phase 3 study 29% who received HTX-011, 11% who received bupivacaine HCl, and 2% who received placebo were opioid-free through 72 hours. In this study AEs were reported by 20 patients (64.5%); none were severe and the most common were nausea (23%) and vomiting (10%). There was no evidence of gastrointestinal, renal, or hepatic toxicity.
Conclusion: HTX-011 when used as the foundation of a non-opioid MMA regimen including scheduled ibuprofen and acetaminophen was able to maintain pain in the mild range resulting in the elimination of postoperative opioid use in 77% of patients after bunionectomy through the 28-day recovery period. Use of HTX-011 demonstrated reduced opioid prescriptions upon discharge. This study also provided evidence that ibuprofen and acetaminophen can safely be administered with HTX-011.